Page 224 - The Handbook for Quality Management a Complete Guide to Operational Excellence

n audit is a comparison of observed activities and/or results with
documented requirements. The evidence provided from audits
Aforms the basis of improvement in either the element audited, or
in the requirements. Effective quality auditing can prevent problems by
uncovering situations that, while still acceptable, are trending toward an
eventual problem. The attention of management brought on by an unfa-
vorable audit report can often prevent future noncompliance.
ISO 19011, Guidelines for Auditing Quality Systems, defines a quality
audit as a
systematic, independent and documented process for obtaining audit evidence
(records, statements of fact or other information, which are relevant to the audit
criteria and verifiable) and evaluating it objectively to determine the extent to which
the audit criteria (set of policies, procedures or requirements) are fulfilled.

Review activities must meet several criteria to be considered audits.
Informal walk-throughs, while useful, do not qualify as systematic evalu-
ation, so do not meet the criteria for an audit. Examinations by employees
who report to the head of the function being examined are also important,
but are not audits. The reference to “policies, procedures or requirements”
implies the existence of written documentation.
Undocumented quality systems are not proper subject matter for qual-
ity audits. Implementation is audited by comparing the planned policies,
procedures, or requirements with observed practices, with an eye toward
whether or not (1) these are properly implemented, and (2) if so, do they
accomplish the stated objectives?
It is no surprise to find that an activity as important and as common as
quality audits is covered by a large number of different standards. It is in
the best interest of all parties that the audit activity be standardized to the
extent possible. One of the fundamental principles of effective auditing is
“no surprises,” something easier to accomplish if all parties involved use
the same rule book. Audit standards are, in general, guidelines that are
voluntarily adopted by auditor and auditee. Often the parties make com-
pliance mandatory by specifying the audit standard as part of a contract.

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